VALIDATION OF ANALYST (MICROBIOLOGIST)

1.0 OBJECTIVE
To lay down a procedure to establish capability of Microbiologist to perform analysis accurately.
2.0 SCOPE
This SOP is applicable to Quality Control Department (Microbiology lab.)
3.0 RESPONSIBILITY
Quality Control Executive
4.0 ACCOUNTABILITY
Department Head
5.0 PROCEDURE
5.1 Samples of known microbial load shall be identified by the Executive
5.2 The microbial load of Sample(s) alongwith acceptable limit(s) , A.R.No., and code No., shall be recorded by Executive in a register maintained for this purpose with following details:
1. S. NO.
2. PRODUCT
3. B.NO.
4. CODE
5. MFG. DATE
6. EXP. DATE
7. ALLOTTED TO
8. INITIAL MICROBIAL LOAD
9. RESULTS
10. VARIANCE
11. REMARKS
5.3 All the coded samples shall be kept in sealed vials at 2 - 8 OC.
5.4 The coded samples alongwith necessary information required for analysis shall be disclosed to the microbiologist.
5.5 The validation shall include involving following methods of analysis.
1. Total microbial count
2. analysis of selective pathogens
3. Identification of bacteria by Gram stain
4. Bacterial endotoxin test
5. Sterility testing
5.6 The results of analyst shall be checked for cGMP compliance and compared with expected values .
5.7 The capability to perform tests by microbiologist shall be considered satisfactory if the results reported by the microbiologist are within the acceptable limits.
TEST...............................................ACCEPATNCE CRITERIA
Total microbial count..........................................+ 10 %
pathogens.....................................................shall be comparable
Identification of bacteria by gram stain...shall be comparable
Bacterial endotoxin test....................................With in range
Sterility testing............................................Shall be comparable
5.8 The analyst shall be revalidated every one year.
5.9 The details like data, strip charts alongwith comments of Manager
- Quality Control shall be filed in training file of microbiologist.